CROs juggle uncertainty, optimism

August 10, 2010 – 6:29 pm by Michael Christel

The latest earnings season for the top publicly traded contract research organizations is over, leaving eyes now focused ahead at just what path clinical outsourcing will take the rest of the year and beyond. [...]

Tags: CRO, outsourcing

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Endo a lot more than just Percocet

July 20, 2010 – 5:20 pm by Chris

Executives at Chadds Ford, Pa.-based Endo Pharmaceuticals have had a busy few weeks. CEO Dave Holveck and Dr. Ivan Gergel, executive VP, research and development, were among the Endo executives who got to ring the opening bell of the Nasdaq on Monday to mark the company’s 10th anniversary trading on that exchange (in the photo, [...]

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Mental illness R&D reaches record level

July 20, 2010 – 2:06 pm by Michael Christel

Offering further proof of the lucrative appeal of mental health drugs despite the continuing minefield for researchers, there are a record 313 new drugs in development to treat conditions ranging from Alzheimer’s disease and depression to schizophrenia and addictive disorders, according to a new report by the Pharmaceutical Researchers and Manufacturers of America. [...]

Tags: Alzheimer's disease, clinical trials, mental illness, PhRMA

Posted in Uncategorized, clinical trials | 2 Comments »

Recruitment reigns at DIA

June 18, 2010 – 6:06 pm by Michael Christel

Patient recruitment and retention was a major theme at this week’s 46th DIA Annual Meeting in Washington, both in the educational sessions and on the show floor. By my count, the conference featured at least 11 panels exploring the topic, ranging in focus from who should be accountable for patient enrollment, to defining realistic [...]

Posted in CRO, Uncategorized, clinical trials | 1 Comment »

Wave of momentum for cancer immunotherapies

June 4, 2010 – 6:28 pm by Michael Christel

Since the landmark approval of Provenge in late April for prostate cancer, much has been made of the significant buzz created for similar cancer immunotherapies that stimulate a patient’s immune system to recognize, attack, and kill tumor cells. We look at one biotechnology company’s efforts in this area ahead. [...]

Tags: antibodies, immunotherapy, leukemia, prostate cancer, Provenge

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Long path for Prolia

June 2, 2010 – 4:49 pm by Michael Christel

Amgen’s anticipated bone-strengthening drug, also known as denosumab, has notched approvals in Europe and the United States in the last five days, the latter almost two months ahead of schedule. A whirlwind week to say the least for Amgen, a company whose fate, fair or not, has been pegged largely on Prolia, a twice-yearly injection that executives say is the most potent agent ever introduced to block bone degradation. While you can tie a nice bow on the events of the last week, the road that preceded was not nearly as swift for the potential blockbuster biologic. [...]

Tags: Amgen, bone loss, cancer, denosumab, FDA, osteoporosis, Prolia

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NIH wants tighter oversight of research money trail

May 28, 2010 – 10:37 am by Michael Christel

In our May cover story on patient recruitment, we talk a bit about the issue of transparency and how the federal government and industry are seemingly taking steps to better address public trust concerns in the research process. The latest example is a new conflict of interest rule being proposed by the National Institutes of Health that would require NIH-funded researchers to disclose more information about their financial ties to industry. The hope for the rule [...]

Tags: NIH, transparency

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Why FBI was at BIO, and why scientists should wake up

May 13, 2010 – 12:07 pm by Chris

In the far back of the exhibit hall in McCormick Place at BIO 2010, in a quiet corner, two well-dressed men were sitting at an understated booth. But they were not with any pharmaceutical or biotech company, or a law firm, or with any of the state, regional, or national pavilions that dominated the convention.
They [...]

Tags: BIO 2010, FBI, pharma, security

Posted in Uncategorized | 2 Comments »

Tool addresses biologic registration limits

May 7, 2010 – 5:52 pm by Michael Christel

Scientific software company Accelrys Inc. recently unveiled the world’s first multi-entity, production-ready biologics registration system, designed to help companies overcome the historically difficult IT challenges associated with registering and defining complex biological materials. Ahead, Frank Brown, Ph.D., Accelrys senior VP and chief science officer, discusses the new tool and its potential in streamlining the knowledge management process for biologics. [...]

Tags: Accelrys, biotechnology

Posted in antibodies, drug discovery | No Comments »

Some thoughts from BIO 2010 (or how not to handle media)

May 6, 2010 – 2:26 pm by Chris

It’s been a hectic two and a half days in Chicago at BIO 2010, the Biotechnology Industry Organization’s annual convention. I’ve interviewed people from Scottish Enterprise and Berlin Partner about their efforts to attract life sciences investment in their regions; sat down with experts from Deloitte and Ernst & Young to discuss the findings revealed [...]

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